Steerable Guide Member and Catheter

ABSTRACT

Medical devices are described and illustrated herein. In particular, steerable guide members and catheters useful in the identification and treatment of bodily passages are provided. Methods of identifying and treating bodily passages are also provided.

FIELD

The invention relates generally to the field of medical devices. Moreparticularly, the invention relates to steerable guide members andcatheters useful in the identification and treatment of bodily passages.

BACKGROUND

It is sometimes necessary or otherwise desirable to treat bodilypassages using a balloon catheter. For example, when sinus cavitiesbecome blocked, balloon sinuplasty, the dilation of the sinus using aballoon catheter, provides an alternative to radical surgical approachesto unblocking the sinus.

Conventional sinuplasty procedures place a balloon catheter over apreviously placed wireguide and are complicated by the need to use x-rayor other visualization equipment to verify positioning of the balloonand wireguide in the proper sinus cavity prior to the actual dilationprocedure. Lighted wireguides have been developed to facilitate thevisualization process, but still present significant drawbacks. Forexample, lighted wireguides cannot be torqued because they typicallyinclude a coil that extends the entire length of the wireguide and lacka rigid inner member. As a result, these devices are not steerable,which limits the ability of a user to navigate the device towards apoint of treatment.

In addition, with respect to treating an airway, such as the trachea, auser generally advances a balloon catheter freely towards a point oftreatment beyond the vocal chords. These devices do not allow a user tosteer the distal end of the catheter through the anatomy of a patient.Therefore, to complete treatment, a user continuously advances andwithdraws the distal end of the catheter from a portion of the airway tonavigate past the vocal chords. As a result, the complexity and thelength of time the procedure takes to complete are increased.

Therefore, a need exists for steerable guide members and cathetersassemblies that include such guide members.

SUMMARY

Several exemplary guide members and medical devices are describedherein. For example, several exemplary guide members and medical devicesadapted to be used with a light source and/or camera for theidentification and treatment of bodily passages are described herein.

An exemplary guide member that is adapted to be used with a light sourcefor the identification and treatment of a bodily passage comprises anelongate tubular member, a coil member, and an optical fiber. Theelongate tubular member has a first proximal end and a first distal end,and defines a first lumen that extends between the first proximal endand the first distal end. The coil member has a second proximal end anda second distal end, and defines a second lumen that extends between thesecond proximal end and the second distal end. The second proximal endof the coil member is attached to the first distal end of the elongatetubular member. The optical fiber is disposed in the first lumen of theelongate tubular member and the second lumen of the coil member. Theoptical fiber has a third proximal end that is adapted to be operativelyconnected to the light source and a third distal end that is attached tothe coil member. The coil member is flexible and is adapted to define acurve that is disposed between the second proximal end and the seconddistal end.

An exemplary medical device that is adapted to be used with a lightsource for the identification and treatment of a bodily passagecomprises a catheter and a guide member. The catheter comprises anelongate main body and a balloon attached to the elongate main body. Theelongate main body has a first proximal end and a first distal end anddefines a first lumen. The balloon is adapted to move between a deflatedconfiguration and an inflated configuration. The guide member isdisposed within the first lumen of the elongate main body and comprisesan elongate tubular member, a coil member, and an optical fiber. Theelongate tubular member has a second proximal end and a second distalend, and defines a second lumen that extends between the second proximalend and the second distal end. The coil member has a third proximal endand a third distal end, and defines a third lumen that extends betweenthe third proximal end and the third distal end. The third proximal endof the coil member is attached to the second distal end of the elongatetubular member. The optical fiber is disposed in the second lumen of theelongate tubular member and the third lumen of the coil member. Theoptical fiber has a fourth proximal end that is adapted to beoperatively connected to the light source and a fourth distal end thatis attached to the coil member. The coil member is flexible and adaptedto define a curve disposed between the second proximal end and thesecond distal end.

Another exemplary medical device that is adapted to be used with a lightsource for the identification and treatment of a bodily passagecomprises a catheter and a guide member. The catheter comprises anelongate main body and a balloon attached to the elongate main body. Theelongate main body has a first proximal end and a first distal end anddefines a first lumen. The balloon is adapted to move between a deflatedconfiguration and an inflated configuration. The guide member isdisposed within the first lumen of the elongate main body and comprisesan elongate tubular member, a fitting, a coil member, and an opticalfiber. The elongate tubular member has a second proximal end and asecond distal end, and defines a second lumen that extends between thesecond proximal end and the second distal end. The fitting is releasablyattached to the elongate tubular member and extends radially outwardfrom the elongate tubular member. The coil member has a third proximalend and a third distal end, and defines a third lumen that extendsbetween the third proximal end and the third distal end. The thirdproximal end of the coil member is attached to the second distal end ofthe elongate tubular member. The optical fiber is disposed in the secondlumen of the elongate tubular member and the third lumen of the coilmember. The optical fiber has a fourth proximal end that is adapted tobe operatively connected to the light source and a fourth distal endthat is attached to the coil member. A portion of the optical fiber isattached to the elongate tubular member. The coil member is flexible andadapted to define a curve disposed between the second proximal end andthe second distal end. The guide member is movable within the firstlumen between a first position and a second position. In the firstposition, the third distal end of the coil member is disposed in a firstcoil position relative to the first distal end of the elongate mainbody. In the second position, the third distal end of the coil member isdisposed in a second coil position relative to the first distal end ofthe elongate main body.

In addition, several exemplary methods of identifying and treatingbodily passages are described herein. For example several exemplarymethods using exemplary guide members and/or medical device areprovided.

Additional understanding of the devices and methods contemplated and/orclaimed by the inventors can be gained by reviewing the detaileddescription of exemplary embodiments, presented below, and thereferenced drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side view of an exemplary guide member.

FIG. 1A is a sectional view of the guide member illustrated in FIG. 1,taken along line 1A-1A in FIG. 1.

FIG. 2 is a side view of an exemplary catheter disposed over the guidemember illustrated in FIG. 1.

FIG. 2A is a sectional view of the catheter illustrated in FIG. 2, takenalong line 2A-2A in FIG. 2.

FIG. 3 is a side view of another exemplary catheter disposed over theguide member illustrated in FIG. 1.

FIG. 3A is a sectional view of the catheter illustrated in FIG. 3, takenalong line 3A-3A in FIG. 3.

FIG. 4 is a flowchart representation of an exemplary method oftreatment.

FIG. 5 is a flowchart representation of another exemplary method oftreatment.

FIG. 6 is a flowchart representation of another exemplary method oftreatment.

FIG. 7 is a flowchart representation of another exemplary method oftreatment.

FIG. 8 is a flowchart representation of another exemplary method oftreatment.

FIG. 9 is a flowchart representation of another exemplary method oftreatment.

FIG. 10 is a flowchart representation of another exemplary method oftreatment.

DETAILED DESCRIPTION

The following description of exemplary embodiments provides illustrativeexamples of that which the inventors regard as their invention. As such,the embodiments discussed herein are merely exemplary in nature and arenot intended to limit the scope of the invention, or its protection, inany manner. Rather, the description of these exemplary embodimentsserves to enable a person of ordinary skill in the relevant art topractice the invention.

As used herein, the term “bodily passage” refers to any passage withinthe body of an animal, including, but not limited to, humans, andincludes elongate passages. The term “sinus passage” refers to the nasalpassages and includes, but is not limited to, eustachian tube(s),primary ostium, and/or accessory ostium. The term “airway” refers to anyairway including, but not limited to, the nasopharynx, oropharynx,pharynx, trachea, bronchial tubes, esophagus, and/or lungs. The term“sinus cavity” refers to the frontal, ethmoid, sphenoid, and/ormaxillary sinus. The term “damage” refers to shattering, cracking,breaking, fracturing, fragmenting, puncturing, penetrating, ripping,tearing, dilating, and/or perforating. The term “attached” refers to thefixed, releasable, or integrated association of two or more elementsand/or devices. Thus, the term “attached” includes releasably attachingor fixedly attaching two or more elements. The term “medication” refersto any fluid, drug, and/or agent used to treat a patient.

FIGS. 1 and 1A illustrate an exemplary guide member 100 comprising anelongate tubular member 120, coil member 140, projection 160, fitting180, and an optical fiber 190.

The elongate tubular member 120 comprises a lengthwise axis 121extending through its length, a proximal end 122, a distal end 124, anda wall 126. The wall 126 has an interior surface 125, an exteriorsurface 127, and defines a lumen 128 that extends between openings atthe proximal end 122 and distal end 124. The elongate tubular member 120is formed of a rigid material such as nickel titanium, however, othermaterials, including semi-rigid materials, are considered suitable, andskilled artisans will be able to select an appropriate materialaccording to a particular embodiment base on various considerations,such as the procedure being performed, among others. Examples ofmaterials considered suitable include, but are not limited to,biocompatible materials, stainless steel, and the like.

The coil member 140 comprises a proximal end 142, distal end 144, lumen146, and curve 148. The coil member 140 defines lumen 146 betweenopenings at the proximal end 142 and the distal end 144. The coil member140 is formed of a flexible material and is adapted to define curve 148between the proximal end 142 and the distal end 144. A skilled artisanwill be able to select a suitable material for a coil member accordingto a particular embodiment based on various considerations, such as theintended use of the device. An example material considered suitable toform a coil member includes, but is not limited to, biocompatiblematerials, nickel titanium, stainless steel, and the like.

Curve 148 can be formed in the coil member 140 using various techniques(e.g., by pulling the coil over a blunt object), and skilled artisanswill be able to select an appropriate method for forming the curveaccording to a particular embodiment based on various considerations,such as the type of procedure to be completed, among others.

The proximal end 142 of coil member 140 is attached to the distal end124 of the elongate tubular member 120. Attachment between the proximalend 142 of the coil member 140 and the distal end 124 of the elongatetubular member 120 can be accomplished using a variety of techniques,and skilled artisans will be able to select an appropriate techniqueaccording to a particular embodiment based on various considerations,such as the configuration of the distal end 124 of the elongate tubularmember 120, and/or the configuration of the proximal end 142 of the coilmember 140, among others. Examples of suitable methods of attaching thecoil member 140 to the elongate tubular member 120 include, but are notlimited to, fusing, welding, adhering, and/or soldering the proximal end142 of the coil member 140 to the distal end 124 of the elongate tubularmember 120.

While the proximal end 142 of the coil member 140 has been described asattached to the distal end 124 of the elongate tubular member 120, thedistal end 124 of the elongate tubular member 120 and/or the proximalend 142 of the coil member 140 can have any suitable structuralarrangement to accomplished attachment between the elongate tubularmember 120 and coil member 140. A skilled artisan will be able to selecta suitable configuration according to a particular embodiment based onvarious considerations, including the intended use of the device.Example structural arrangements considered suitable include, but are notlimited to, using a butt joint, extending a coil radially outward suchthat a distal end of an elongate tubular member can be introduced into alumen of the coil member, and/or providing an elongate tubular memberwith a distal end that defines a taper such that the distal end of theelongate tubular member can be introduced into a lumen of a coil member.

Optionally, a lubricious coating can be included along a portion, or theentirety, of the length of the elongate tubular member 120 and/or thecoil member 140. Any suitable lubricious coating can be used, andskilled artisans will be able to select a suitable lubricious coatingaccording to a particular embodiment based on various considerations,such as the bodily passage within which the device is intended to beused. Examples of lubricious coatings considered suitable include, butare not limited to, polymers such as polytetrafluoroethylene (PTFE), andany other polymer or substance having properties that result in thelowering of the coefficient of friction between the outer surface of theelongate tubular member 120 and/or the coil member 140 and the surfacein which the outer surface of the elongate tubular member 120 and/orcoil member 140 is intended to, or may, contact.

Various alternative structural arrangements of the coil member 140 areconsidered suitable for inclusion with a guide member 100. For example,the curve 148 of the coil member 140 can be omitted, or multiple curvescan be incorporated into, and defined by, the coil member 140. Inaddition, alternative to attaching a coil member 140 to the distal end124 of an elongate tubular member 120, which can be formed of the same,or different material as the coil member 140, the distal end of theelongate tubular member can be laser cut into a spiral configuration toprovide a guide member 100 with a flexible distal end. In thisconfiguration, the elongate tubular member and the coil member can beformed of the same material.

Projection 160 is disposed on the exterior surface 127 of the wall 126of the elongate tubular member 120 between the proximal end 122 and thedistal end 124 of the elongate tubular member 120. The projection 160extends radially outward from the elongate tubular member 120 and can befixedly attached, removably attached, integral with, or separate fromthe elongate tubular member 120. Projection 160 extendscircumferentially about the entirety of the elongate tubular member 120,however, other configurations are considered suitable. For example, theprojection 160 can circumferentially extend around a portion of theelongate tubular member 120. Projection 160 advantageously provides amechanical stop for limiting proximal and distal progression of theguide member 100 when used in combination with a catheter, as describedin more detail below. Alternatively, projection 160 can be omitted toallow a device to be advanced over a length of the guide member 100.

While the elongate tubular member 120 and the projection 160 have beendescribed as being circular in nature, other configurations areconsidered suitable, and skilled artisans will be able to select anappropriate configuration according to a particular embodiment based onvarious considerations, such as the configuration of the recess 232 andguide member lumen 230 of the main body 220 of the catheter 200, amongothers.

Fitting 180 is disposed on the proximal end 124 of the elongate tubularmember 120 and extends radially outward from the elongate tubular member120. Fitting 180 can be fixedly attached, removably attached, integralwith, or separate from the elongate tubular member 120. Fitting 180 isconfigured to communicate torque to the attached elongate tubular member120 and coil member 140 when the user rotates the fitting 180. Thefitting 180 can have any suitable configuration, and skilled artisanswill be able to select an appropriate configuration for a particularembodiment based on various considerations, such as the amount of torqueto be communicated to the coil member 140, among others. For example,the fitting 180 can circumferentially extend about the entirety of, or aportion of, the elongate tubular member 120. In addition, when fitting180 is releasably attached to the fitting 180 any suitable method ofattachment can be utilized, and skilled artisans will be able to selecta suitable means for attachment based on various considerations, such asthe intended use of the device. Examples methods considered suitableinclude, but are not limited to, using threaded components, snap fit, orotherwise. Alternatively, the fitting can be omitted from the guidemember.

Optical fiber 190 extends between a proximal end 192 and a distal end194 and defines a light path extending through its length. The opticalfiber 190 is disposed within, and extends through, the lumen 128 of theelongate tubular member 120 (e.g., first optic lumen), and the lumen 146of coil member 140 (e.g., second optic lumen). The proximal end 192 ofthe optical fiber is adapted to be operatively connected, and/orattached, to a light source 198. The distal end 194 of the optical fiber190 is attached to the coil member 140. The optical fiber 190 can beattached to the interior surface 125 of the wall 126 of the elongatetubular member 120, and/or the coil member 140, at a variety oflocations along the length of these components. For example, the opticalfiber 190 can be attached along the entire length, or at one or morelocations along the length, of the elongate tubular member 120 and/orthe coil member 140, such as at locations 191.

Attaching the optical fiber 190, or a portion thereof, at one or morelocations along the length of the elongate tubular member 120 and/orcoil member 140 is considered advantageous at least because it increasesthe torquability of the guide member 100 while maintaining flexibilityof the coil member 140. For example, a portion of the optical fiber 190can be attached at the distal end 124 of the elongate tubular member 120and another portion of the optical fiber 190 can be attached at thedistal end 144 of the coil member 140. Attachment of the optical fiber190 to the elongate tubular member 120 and/or coil member 140 can beaccomplished using any suitable method of attachment, and skilledartisans will be able to select a suitable method of attachment based onvarious considerations, such as the intended use of the device. Anexample of a suitable method of attachment includes, but is not limitedto, using an adhesive, fusing, and/or welding.

The optical fiber 190 can be configured to emit light axially and/orradially. For example, axially-directed light can be emitted distallyfrom the distal end 194 of the optical fiber 190, whileradially-directed light can be emitted radially by the optical fiber 190distal to, or within, coil member 140 and/or elongate tubular member120. While the optical fiber 190 has been described and illustrated asattached to the coil member 140, the optical fiber 190 can,alternatively, be omitted from the guide member 100 and providedseparately.

Attaching the optical fiber 190 to the coil member 140 and/or elongatetubular member 120 can be accomplished using various methods, materials,and at various times during assembly of the guide member 100. Forexample, the optical fiber 190 can be inserted through the lumen 128 ofthe elongate tubular member 120 and lumen 146 of the coil member 140before, during, or after the coil member 140 has been attached to theelongate tubular member 120. The distal end 194 of the optical fiber 190can then be trimmed accordingly. In an example where the coil member 140is adhesively attached to the elongate tubular member 120, the opticalfiber 190 can be inserted into the lumen 128 of the elongate tubularmember 120 and the lumen 146 of the coil member 140 prior to joining thecoil member 140 to the elongate tubular member 120, which assists inattaching the coil member 140 to the elongate tubular member 120.

Any suitable optical fiber 190 can be used in the guide member 100.Commercially available optical fibers considered suitable for use in theguide members described herein include plastic optical fibers and glassoptical fibers, with or without cladding. The optical fiber 190 can haveany suitable length, and skilled artisans will be able to select anappropriate length for inclusion in a guide member according to aparticular embodiment based on various considerations, such as theintended use of the guide member, among others. For example, the opticalfiber 190 can be trimmed flush with, proximal to, or distal to thedistal end 144 of the coil member 140. The optical fiber 190 can includea length that allows a portion of the optical fiber to extend proximalto the proximal end 122 of the elongate tubular member 120 to the lightsource 198. When the optical fiber 190 extends proximal to the proximalend 122 of the elongate tubular member 120 an extension sheath (notshown) can be disposed over the optical fiber 190 from the proximal endof the elongate tubular member to the light source 198.

Optionally, the optical fiber 190 can define a curve between itsproximal end 192 and the distal end 194. The curve can be formed usingvarious techniques, and skilled artisans will be able to select anappropriate method for forming a curve in a optical fiber according to aparticular embodiment based on various considerations, such as the typeoptical fiber being used. An example technique considered suitable toform a curve in a optical fiber 190 includes, but is not limited to,heating a portion of the optical fiber 190 as it is maintained in acurved shape to incorporate memory of the curve into the optical fiber190.

The light source 198 is operatively attached to the proximal end 192 ofthe optical fiber 190 and includes a fiber coupling 199 which providescommunication between the light source 198 and the optical fiber 190.Light generated by the light source 198 travels through the light pathdefined by the optical fiber 190 and is emitted axially, and/orradially, from the optical fiber 190. Alternatively, the proximal end122 of the elongate tubular member 120 can include one or moreconnectors for attaching the light source 198 to the elongate tubularmember 120. The light source 198 can include one or more switches toallow a user to selectively turn on and off, or dim, optical fiber 190.While the light source 198 has been described and illustrated asattached to the proximal end 192 of the optical fiber 190, the lightsource 198 can, alternatively, be omitted from the guide member 100 andprovided separately.

Any suitable light source 198 can be used with the guide member 100.Commercially-available light sources considered suitable for use withthe guide member 100 include xenon, laser, LED, halogen, and othersuitable light sources. While particular light sources have beendescribed, skilled artisans will be able to select an appropriate lightsource for inclusion in a guide member according to a particularembodiment based on various considerations, including the location ofthe bodily passage being identified and/or treated, among others.

It is noted that, while a single optical fiber 190 is described andillustrated, two or more optical fibers can be used to independently toprovide axially-directed and/or radially-directed light. The two or moreoptical fibers can each extend through the lumen 126 of the elongatetubular member 120 and the lumen 146 of the coil member 140 and can beoperatively attached to the same light source, or two separate lightsources. Optionally, the two or more optical fibers can be omitted fromthe guide member 100 and provided separately.

Alternatively, the optical fiber can comprise two separate lengths, afirst length disposed in the lumen 128 of the elongate tubular member120 extending between the proximal end 122 and the distal end 146 of thecoil member 140 and a second length extending from the fitting 180 tothe light source 198. In this embodiment, the fitting 180 includes anysuitable method of attaching the first length and the second length toone another such that light can travel between a light path defined bythe first length and a light path defined by the second length. Askilled artisan will be able to select a suitable method for attachingthe first length to the second length according to a particularembodiment based on various considerations, such as the intended use ofthe device. An example of a suitable method of attaching the firstlength to the second length includes, but is not limited to, using aoptical fiber coupling.

In this embodiment, the fitting 180 is releasably attached to theproximal end 122 of the elongate tubular member 120 and projection 160is omitted to allow any suitable medical device to be advanced over theguide member 100. A skilled artisan will be able to select any suitablemedical device to use in combination with a guide member according to aparticular embodiment based on various considerations, such as theintended use of the device. Example devices considered suitable toadvance over a length of an elongate tubular member include, but are notlimited to, catheters, irrigation catheters, balloon catheters, and anyother suitable medical device.

Alternative to, or in addition to, the use of an optical fiber 190, theguide member 100 can optionally include a camera disposed on the distalend of the coil member 140 configured to transmit images to a displayfor a user to determine the location of the distal end of the guidemember, and/or the catheter(s) as described below. The camera caninclude any device suitable for capturing and transmitting an image viahard wire and/or wirelessly to a display. For example, if the camera iswired to a display, the wire connecting the camera to the display canhave a distal end connected to the camera, a length disposed through thelumen 126 of the elongate tubular member 120 and the lumen 146 of thecoil member 140, and a proximal end connected to a display device,memory device, and/or a receiver.

In use, the optical fiber 190 and/or camera enables a user to identifythe placement of the guide member 100 within a bodily passage and allowsthe user to selectively navigate through the anatomy of a patient. Forexample, the user can identify placement of the guide member 100 byactivating the light source 198 and locating the axially and/orradially-directed light emitting from the optical fiber 190. In anotherexample, the user can navigate through the anatomy of a patient byrotating the fitting 180 and, therefore, the coil member 140 to advancethe guide member 100 towards a point of treatment. When the coil member140 includes curve 148, or multiple curves, the user can advantageouslydirect the distal end 144 of the coil member 140 selectively in thedirection of the point of treatment. The inclusion of a rigid, orsemi-rigid, elongate tubular member 120 in guide member 100 increasesthe torquability of the coil member 140, providing a user with theability to navigate the anatomy of a patient.

FIGS. 2 and 2A illustrate an exemplary catheter 200 disposed over guidemember 100. The catheter 200 comprises a proximal end 202, distal end204, an elongate main body 220, a balloon 240, and a collar 250. Whileexemplary catheter 200 includes a balloon, any suitable medical devicecan be used in combination with the guide members described herein, andskilled artisans will be able to select a suitable medical deviceaccording to a particular embodiment based on various considerations,such as the desired procedure to be accomplished. Example medicaldevices considered suitable include, but are not limited to, catheters,irrigation catheters, balloon catheters, and any other suitable medicaldevice.

The main body 220 comprises a proximal end 222, distal end 224 and awall 225 that defines an inflation port 226, inflation lumen 228, guidemember lumen 230, recess 232, and shoulder 234. The inflation lumen 228extends between the inflation port 226 and an opening 227 disposedbetween the proximal end 222 and the distal end 224 of the main body220. The guide member lumen 230 extends between the proximal end 222 andthe distal end 224 of the main body 220. The recess 232 extends from theproximal end 222 of the main body into the guide member lumen 230towards the distal end 224 of the main body 220 and has a first diameter235. The shoulder 234 extends radially into the recess 232 and defines asecond diameter 237 that extends from the distal end of the recess 232to the distal end 224 of the main body 220. The first diameter 235 ofthe recess 232 is greater than the second diameter 237 defined by theshoulder 234 and is configured to receive projection 160. The seconddiameter 237 is configured to receive a portion of the elongate tubularmember 120 and the coil member 140 of the guide member 100.

Alternative to defining shoulder 234, the wall 225 of the main body 220can define a tapered and/or sloped recess configuration adapted to limitthe distal advancement of the projection 160 within the recess.Therefore, the configuration of the projection 160 and/or proximal endof the guide member lumen 230 can vary, and skilled artisans will beable to select an appropriate configuration for inclusion in a catheteraccording to a particular embodiment based on various considerations,such as the configuration of the projection, and/or guide member lumen,among others.

In a further alternative, the main body 220 can define a guide memberlumen having a continuous inner diameter, such as when the fitting 180is releasably attached to the proximal end 122 of the elongate tubularmember 120 and the projection 160 has been omitted.

The guide member 100 is disposed within the guide member lumen 230 ofthe main body 220 such that projection 160 is disposed within the recess232 of the guide member lumen 230 and fitting 180 is disposed proximalto the proximal end 222 of the main body 220. Projection 160 is adaptedto interact with shoulder 234 to stop distal progression of the guidemember 100 through the guide member lumen 230 when a distal force isplaced on the guide member 100 (e.g., on fitting 180). In addition,projection 160 is adapted to interact with fitting 180 to stop proximalprogression of the guide member 100 through the guide member lumen 230when a proximal force is placed on the guide member 100 (e.g., onfitting 180). This structural arrangement advantageously allows theguide member 100 to be advanced distally and withdrawn proximally toassist in navigating the catheter 200 to a point of treatment.Furthermore, this structural arrangement advantageously provides a guidemember 100 that is rotatable 360° within the guide member lumen 230 toassist a user in navigating the catheter 200 to a point of treatment.Alternatively, as described above, the projection 160 can be omitted andthe fitting 180 can be releasably attached to the proximal end 124 ofthe elongate tubular member 120 so that any suitable medical device canbe advanced over the guide member 100.

The distal end of the optical fiber 190 can be disposed at any suitablelocation along the length of the coil member 140 and/or elongate tubularmember 120. For example, when disposed in the guide member lumen 230,the optical fiber 190 can be cut at a length which disposes its distalend 194 at a location distal to, proximal to, and/or at the distal end224 of the main body 220.

Collar 250 is attached to the proximal end 222 of the main body 220 anddefines a passageway 251 that permits movement of the elongate tubularmember 120 therethrough and prevents, or substantially prevents,movement of the projection 160 therethrough. Thus, the collar 250advantageously provides for retaining the projection 160 within therecess 232 of the main body 220 and stopping proximal progress of theguide member 100 when a proximal force is placed on the guide member 100(e.g., fitting 180). In an alternative, collar 250 can be omitted, orprovided separately.

Balloon 240 is attached to the distal end 224 of the main body 220 andis configured to move between a deflated configuration and an inflatedconfiguration. The material of the balloon 240 and the portion of theexterior surface of the main body 220 positioned within the balloon 240define an inflation chamber 242. The balloon 240 is positioned on thedistal end 224 of the main body 220 such that opening 227 is incommunication with the inflation chamber 242. With this structuralarrangement, the balloon 240 can move between the deflated and inflatedconfigurations as fluid is moved into and out of the inflation chamber242 via the opening 227, inflation lumen 228, and inflation port 226.

A user inflates the balloon 240 by introducing a fluid (e.g., saline)into the inflation lumen 228 until the fluid passes through the opening227 and into the inflation chamber 242. The resulting pressure placed onthe inner surface of the balloon 240 by the fluid causes the balloon 240to inflate and adopt the inflated configuration. To move the balloon 240to the deflated configuration, vacuum pressure can be applied to theinflation lumen 228 to remove fluid located within the inflation chamber242 via the opening 227, resulting in the balloon 240 collapsing andreturning to a deflated configuration. FIG. 2 illustrate the balloon 240in the inflated configuration.

It is considered advantageous to provide a coil member 140 and/orelongate tubular member 120 with a length sufficient to have to thedistal end 144 of the coil member 140 extend distal to the distal end224 of the main body 220 when the projection 160 is retracted proximallyto interact with collar 250. Alternatively, a coil member 140 and/orelongate tubular member 120 with a length sufficient to have to thedistal end 144 of the coil member 140 disposed proximal to the distalend 224 of the main body 220 when the projection 160 is retractedproximally to interact with collar 250 is considered suitable. Thus, theguide member 100 is moveable within the guide member lumen 230 between afirst position and a second position. In the first position, the distalend 144 of the coil member 140 is disposed in the first coil positionrelative to the distal end 224 of the main body of the 220. In thesecond position, the distal end 144 of the coil member 140 is disposedin a second coil position relative to the distal end 224 of the mainbody 220. The first coil position being different from the second coilposition.

The length of the guide member 100, elongate tubular member 120, coilmember 140, and/or optical fiber 190 can vary depending on theconfiguration of the main body 220 and/or balloon 240. However, it isconsidered advantageous to have an elongate tubular member 120 with alength that positions the distal end 124 of the elongate tubular member120 proximal to the proximal end of the balloon 240 to allow forflexibility through the balloon 240. For example, when projection 160 isadvanced distally to interact with shoulder 234, the distal end 124 ofthe elongate tubular member 120 is disposed proximal to the proximal endof the balloon 240.

Alternative to main body 220 extending through the length of the balloon240, as illustrated in FIG. 2, a balloon that defines a lumen thatextends from an opening at the proximal end of the balloon to an openingat the distal end of the balloon can be attached to the distal end ofthe main body. In this embodiment, the distal end of the main body islocated at, or near, the opening defined at the distal end of theinflation lumen. The balloon is attached to the distal end of the mainbody such that the lumen of the balloon is in communication with guidemember lumen and advantageously allows for the coil member to beadvanced through its length and navigate the balloon through tortuouspassages. The material of the balloon, the wall of the lumen extendingthrough the length of the balloon, and the portion of the exteriorsurface of the main body positioned within the balloon define aninflation chamber. The balloon is positioned on the distal end of themain body such that the opening at the distal end of the inflation lumenis in communication with the inflation chamber. With this structuralarrangement, the balloon can move between the deflated and inflatedconfigurations as fluid is moved into and out of the inflation chambervia the opening at the distal end of the inflation lumen, inflationlumen, and inflation port.

When a balloon defines a lumen that extends along its length, the guidemember is disposed within the guide member lumen of the main body andthe lumen of the balloon such that the projection is disposed within therecess of the guide member lumen and fitting is disposed proximal to theproximal end of the main body. This configuration advantageously allowsthe guide member to be advanced distally and withdrawn proximally toassist in navigating the catheter to a point of treatment. Furthermore,this configuration advantageously provides a guide member that isrotatable 360° within the guide member lumen and the lumen of theballoon to assist a user in navigating the catheter to a point oftreatment. Alternatively, as described above, the projection can beomitted and the fitting can be releasably attached to the proximal endof the elongate tubular member so that any suitable medical device canbe advanced over a length of the guide member.

FIGS. 3 and 3A illustrate another exemplary catheter 300 disposed overguide member 100. The catheter 300 is similar to the exemplary catheter200 illustrated in FIG. 2, except as detailed below. The catheter 300includes an elongate main body 320, a first balloon 340, and a secondballoon 360.

The main body 320 comprises a proximal end 322, distal end 324, and awall 321 that defines an inflation port 326, infusion port 328,inflation lumen 330, infusion lumen 332, guide member lumen 334, recess336, shoulder 338, and collar 339. The inflation lumen 330 extendsbetween the inflation port 326 and an opening 327 disposed between theproximal end 322 and the distal end 324 of the main body 320. Theinfusion lumen 332 extends between the infusion port 328 and a secondopening 329 disposed between the proximal end 322 and the distal end 324of the main body 320. The guide member lumen 334 extends between theproximal end 322 and the distal end 324 of the main body 320. The recess336 extends from the proximal end 322 of the main body 320 into theguide member lumen 334 towards the distal end 324 of the main body 320and has a first diameter 335. The shoulder 338 extends radially into therecess 336 and defines a second diameter 337 that extends from thedistal end of the recess 336 to the distal end 324 of the main body 320.The first diameter 335 of the recess 336 is greater than the seconddiameter 337 defined by the shoulder 338 and is configured to receiveprojection 160. The second diameter 337 is sized to receive a portion ofthe elongate tubular member 120 and coil member 140 of the guide member100.

The guide member 100 is disposed within the guide member lumen 334 ofthe main body 320 such that projection 160 is disposed within the recess336 of the guide member lumen 334. Projection 160 is adapted to interactwith shoulder 338 to stop distal progression of the guide member 100through the guide member lumen 334 when a distal force is placed on theguide member 100 (e.g., on fitting 180), allowing the guide member 100to be advanced and withdrawn to assist in advancing the catheter 300 toa point of treatment.

The first balloon 340 and second balloon 360 are disposed on the distalend 322 of the main body 320. The second balloon 360 is disposed withinthe first balloon 340. The material of the first balloon 340, theportion of the exterior surface of the main body 320 positioned withinthe first balloon 340, and the exterior surface of the second balloon360 define an infusion chamber 342. The first balloon 340 is disposed onthe distal end of the main body 320 such that the second opening 329 ofthe infusion lumen 332 is in communication with the infusion chamber342. The material of the second balloon 360 and the portion of theexterior surface of the main body 320 positioned within the secondballoon 360 define an inflation chamber 362. The second balloon 360 isdisposed on the distal end 324 of the main body 320 such that theopening 327 of the inflation lumen 330 is in communication with theinflation chamber 362.

The second balloon 360 is adapted to move between deflated and inflatedconfigurations as fluid is moved into and out of the inflation chamber362 via the inflation port 326, inflation lumen 330 and the opening 327.A user inflates the second balloon 360 by introducing a fluid (e.g.,saline) into the inflation port 326 and through the inflation lumen 328until the fluid passes through the opening 327 into the inflationchamber 362. The resulting pressure placed on the inner surface of thesecond balloon 360 by the fluid causes the second balloon 360 to inflateand adopt the inflated configuration. To move the second balloon 360 tothe deflated configuration, vacuum pressure can be applied to theinflation port 326 to remove fluid located within the inflation chamber362, resulting in the second balloon 360 deflating.

Similar to the second balloon 360, the first balloon 340 is adapted tomove between folded and expanded configurations by way of movement ofthe second balloon 360 between its inflated and deflated configurations.Thus, the user expands the first balloon 340 by inflating the secondballoon 360. To move the first balloon 340 to the folded configuration,vacuum pressure can be applied to the inflation port 326 to remove fluidwithin the inflation chamber 362 resulting the second balloon 360 andthe first balloon 340 returning to their deflated and foldedconfigurations.

The first balloon 340 and second balloon 360 can advantageously includememory imparted onto the balloons by a heat treatment step thatcomprises heating the balloons while they are in their deflated andfolded configurations. This heat treatment, and the resulting memory,gives the balloons a tendency to return to their deflated and foldedconfigurations. Alternatively, the heat treatment step can be omitted orapplied to one of the first balloon 340 or second balloon 360independently. For example, when only the first balloon 340 has beenheat treated, the first balloon 340 will have a tendency to return toits folded configuration when the second balloon 360 is moved from itsinflated configuration to its deflated configuration.

The first balloon 340 includes one or more regions 344 that include oneor more pores 346. Each of the pores 346 extends through the material ofthe first balloon 340 and permits fluid (e.g., medication) to passthrough the wall of the first balloon 340, preferably with theapplication of pressure within the infusion chamber 342. Alternatively,when at least two or more pores 346 are provided, at least two of thepores 346 can vary in diameter. For example, the pores 346 can increasein diameter from the proximal end to the distal end of the first balloon340. In a further alternative, when at least two or more pores 346 areprovided, the pores 346 can increase in number from the proximal end tothe distal end of the first balloon 340. The variable size and numberconfigurations advantageously provide substantially equalizeddistribution and/or reduced pressure drop of the medication as it isbeing passed through the wall of the first balloon 340 from the proximalend to the distal end of the first balloon 340.

The regions 344 can be arranged on the first balloon 340 in any suitableconfiguration. For example, the regions 344 can circumferentially-extendaround the first balloon 340. Other configurations considered suitableinclude a single circumferentially-extending region, multiplecircumferentially-extending regions, a staggered configuration, and/orlinear configuration along the length of the first balloon.

Depending on the size and number of pores 346 defined by the wall of thefirst balloon 340, the first balloon 340 can be adapted to move betweenfolded and expanded configuration as medication is moved into and out ofthe infusion chamber 342 via the infusion port 328, infusion lumen 332and the second opening 329. Configurations that allow for the firstballoon 340 to move between a deflated and inflated configurationadvantageously provide two different inflated configurations for thecatheter 300. For example, a first configuration where the secondballoon 360 is inflated and a second configuration wherein the firstballoon 340 is inflated in combination with the second balloon 360.

While the catheter 300 has been described as including two balloons, afirst outer balloon 340 and a second inner balloon 360, the catheter 300can alternatively comprise a single balloon defining the one or moreregions containing one or more pores as described above. When a singleballoon is disposed on the distal end of the main body, the main bodydefines an infusion port and an infusion lumen and an opening disposedon the distal end of the inflation lumen. The single balloon is disposedon the distal end of the main body and the material of the balloon andthe portion of the exterior surface of the main body disposed within theballoon define an infusion chamber. The balloon is positioned on thedistal end of the main body such that the opening of the infusion lumenis in communication with the infusion chamber. The balloon is adapted tomove between deflated and inflated configurations as medication is movedinto and out of the infusion chamber via the infusion port, infusionlumen and opening. The amount of inflation of the balloon will depend onthe number and diameter of the one or more pores defined by the wall ofthe balloon and the amount, and rate, of medication being introducedinto the infusion chamber.

Additional structure can be attached to the catheters described hereinto facilitate the inflation and deflation of the balloon(s). Forexample, a syringe or other suitable structure can be attached to theinflation port and/or infusion port using any suitable connection, suchas a luer lock connection. The fluid and/or medication can be storedwithin the syringe, inflation lumen, and/or infusion lumen and can beintroduced into and removed from the inflation chamber and/or infusionchamber by operating the syringe using conventional practices.

Alternative to main body 320 extending through the length of the balloon340, as illustrated in FIG. 3, a balloon that defines a lumen thatextends from an opening at the proximal end of the balloon to an openingat the distal end of the balloon can be attached to the distal end ofthe main body. In this embodiment, the distal end of the main body islocated at, or near, the opening defined at the distal end of theinflation lumen. The balloon is attached to the distal end of the mainbody such that the lumen of the balloon is in communication with guidemember lumen and advantageously allows for the coil member to beadvanced through its length and navigate the balloon through tortuouspassages. The material of the balloon, the wall of the lumen extendingthrough the length of the balloon, and the portion of the exteriorsurface of the main body positioned within the balloon define aninflation chamber. The balloon is positioned on the distal end of themain body such that the opening at the distal end of the inflation lumenis in communication with the inflation chamber and the opening at thedistal end of the infusion lumen is in communication with the infusionchamber. With this structural arrangement, the balloon can move betweenthe deflated and inflated, and folded and expanded, configurations asfluid is moved into and out of the inflation chamber and infusionchamber via the opening at the distal end of the inflation lumen and theopening at the distal end of the infusion lumen.

When a balloon defines a lumen that extends along its length, the guidemember is disposed within the guide member lumen of the main body andthe lumen of the balloon such that the projection is disposed within therecess of the guide member lumen and fitting is disposed proximal to theproximal end of the main body. This configuration advantageously allowsthe guide member to be advanced distally and withdrawn proximally toassist in navigating the catheter to a point of treatment. Furthermore,this configuration advantageously provides a guide member that isrotatable 360° within the guide member lumen and the lumen of theballoon to assist a user in navigating the catheter to a point oftreatment. Alternatively, as described above, the projection can beomitted and the fitting can be releasably attached to the proximal endof the elongate tubular member so that any suitable medical device canbe advanced over a length of the guide member.

FIG. 4 is a flowchart representation of an exemplary method 400 oftreating tissue in a bodily passage defined by a passage wall using theexemplary catheter and guide member described above with respect to FIG.2. An initial step 402 comprises inserting a guide member and cathetereach having a proximal end and a distal end into a bodily passage suchthat the distal end of the catheter is disposed in the bodily passage.Another step 404 comprises navigating the distal end of the cathetertowards a point of treatment within said bodily passage. Another step406 comprises navigating the distal end of the guide member towards apoint of treatment. Another step 408 comprises rotating the guide membertowards a point of treatment. Another step 410 comprises advancing theguide member to a point of treatment. Another step 412 comprisesadvancing the catheter to a point of treatment. Another step 414comprises passing a fluid into the balloon. Another step 416 comprisesremoving a portion of the fluid from the balloon. Another step 418comprises withdrawing the distal end of the guide member and catheterfrom the bodily passage.

The step of inserting the distal end of a catheter and guide member intoa bodily passage can be accomplished using the exemplary catheter andguide member described above with reference to FIG. 2. However, whilethe exemplary catheter and guide member described above with referenceto FIG. 2 has been described below as accomplishing the method oftreatment associated with FIG. 4, other catheter configurations, and/ormedical devices, such as those described herein can be utilized toaccomplish the method of treatment associated with FIG. 4, and skilledartisans will be able to select an appropriate catheter and/or medicaldevice according to a particular embodiment based on variousconsiderations, such as the procedure intended to be accomplished, amongothers.

The step of navigating the distal end of the catheter towards a point oftreatment can be accomplished transcutaneously, via display, and/orusing direct visualization (e.g., with a scope). For example, when thedistal end of the catheter comprises a light source and/or camera,navigating the distal end of the catheter towards a point of treatmentcan be accomplished transcutaneously and/or via live feed on a display.In an example, navigating the distal end of the catheter towards a pointof treatment using transcutaneous visualization can be accomplished byvisualizing the intensity of the light transcutaneously to determine ifthe intensity is indicative of proper positioning of the distal end ofthe catheter being directed towards a point of treatment. In anotherexample, navigating the distal end of the catheter towards a point oftreatment can be accomplished by viewing images provided on a displayand determining if the images indicate proper positioning of the distalend of the catheter being direct towards a point of treatment.

The step of navigating the distal end of the guide member towards apoint of treatment can be accomplished by applying a proximal or distalforce on the guide member (e.g., fitting 180) to advance the guidemember in the proximal or distal direction. For example, if it isdetermined in the step of navigating the distal end of the cathetertowards a point of treatment that the distal end of the catheter is notproperly positioned, the user can navigate the guide member in theproximal or distal direction to position the distal end of the guidemember at a location suitable to advance the catheter towards a point oftreatment. In another example, the user may determine that anatomicalfeatures are blocking the advancement of the distal end of the catheter(e.g., vocal chords) and/or that the distal end of the catheter must benavigated through an opening positioned at an angle from which thedistal end of the catheter is currently disposed. In this example, theuser can navigate the guide member in a proximal or distal direction toposition the guide member in a location suitable to advance the cathetertowards a point of treatment around the anatomical features or throughthe opening.

The step of rotating the guide member towards a point of treatment canbe accomplished by rotating the guide member (e.g., fitting 180) in aclockwise or counterclockwise direction around the lengthwise axis ofthe elongate tubular member. For example, if it is determined in thestep of navigating the distal end of the catheter towards a point oftreatment and/or the step of navigating the guide member towards a pointof treatment that the distal end of the catheter is not properlypositioned at a point of treatment and the point of treatment is beyonda passageway located in the wall of the bodily passage, the user canrotate the fitting in either the clockwise or counterclockwise directionaround the lengthwise axis of the elongate tubular member to positionthe distal end of the guide member towards the point of treatmentthrough the passageway.

Depending on the location of the distal end of the catheter within thebodily passage and its position with respect to the intended point oftreatment, the steps of navigating the guide member towards a point oftreatment and/or rotating the guide member towards a point of treatmentcan be omitted, combined, or one of the steps can be omitted.

The step of advancing the guide member to a point of treatment can beaccomplished by advancing the guide member distally and can be confirmedtranscutaneously, via video display, or using direct visualization(e.g., with a scope).

The step of advancing the catheter to a point of treatment can beaccomplished by advancing the catheter over the previously navigatedguide member and can be confirmed transcutaneously, via video display,or using direct visualization (e.g., with a scope). Alternative toadvancing the catheter to a point of treatment, the guide member can beadvanced distally to cannulate the bodily passage with the coil member.In a further alternative, the guide member can be advanced distally tocannulate the bodily passage and then the step of advancing the catheterto a point of treatment can be accomplished. Optionally, the steps ofadvancing the guide member to a point of treatment and advancing thecatheter to a point of treatment can be accomplished concurrently.

The step of passing a fluid through the inflation lumen is accomplishedby passing a fluid (e.g., saline, water, contrast, mixture of one ormore of saline, water, and/or contrast) through the inflation lumen andinto the inflation chamber of the balloon with a pressure sufficient toinflate the balloon and provide contact between a portion, the entirety,or the majority, of the exterior surface of the balloon and the passagewall. The amount of saline introduced into the inflation chamber willdetermine the amount of inflation of the balloon. For example, inprocedures where a large amount of contact and pressure are desiredbetween the exterior surface of the balloon and the passage wall, alarger amount of fluid will be passed through the inflation port intothe inflation chamber. In another example, in procedures where a smalleramount of contact and pressure are desired between the exterior surfaceof the balloon and the passage wall, a smaller amount of fluid will bepassed through the inflation port into the inflation lumen. Examples ofpressures considered suitable include pressures in the range from about1 ATM to about 12 ATM. A pressure gauge, or other similar device, can beused to provide a user with the ability to view the amount of pressurebeing applied at a point of treatment.

The step of removing a portion of the fluid from the balloon can beaccomplished by removing a portion, the entity, or majority, of thefluid passed into the inflation chamber. For example, a syringe incommunication with the inflation port can be used to provide vacuumpressure to remove the fluid from the inflation chamber.

The step of withdrawing the distal end of the guide member and catheterfrom the bodily passage can be accomplished by pulling the catheter andguide member proximally until they are completely removed from thebodily passage and the patient.

Optional steps of inserting the distal end of a cutting tool into thebodily passage, navigating the distal end of the cutting tool to a pointof treatment, cutting tissue from the bodily passage, removing thetissue, and withdrawing the cutting tool can be accomplished prior toinserting the distal end of a catheter into a bodily passage. Anysuitable cutting tool can be used to accomplish these steps. Forexample, the cutting tool can comprise a suction cutter or scalpel. Toaccomplish these steps, an initial step comprises inserting the distalend of a cutting tool into a bodily passage. Another step comprisesnavigating the distal end of the cutting tool to a point of treatment.The step of navigating the distal end of a cutting tool to a point oftreatment can be accomplished using direct and/or transcutaneousvisualization. Another step comprises cutting tissue from the bodilypassage. Another step comprises removing the tissue from the bodilypassage. Another step comprises removing the distal end of the cuttingtool from the bodily passage.

While various catheter configurations, steps, alternative steps, andoptional steps have been described above with respect to treating tissuein a bodily passage, these catheter configurations, steps, alternativesteps, and optional steps can be included in, accomplished concurrentlywith, and/or accomplished in the alternative to, the methodologies,catheter configurations, steps, alternative steps, and/or optional stepsdescribed below with respect to treating tissue in a bodily passage,sinus cavity, airway, and/or sinus passage.

FIG. 5 is a flowchart representation of another exemplary method 500 oftreating tissue in a bodily passage defined by a passage wall using theexemplary catheter and guide member described above with respect to FIG.3. The method 500 is similar to that described above with respect tomethod 400, except as described below. An initial step 502 comprisesinserting a guide member and catheter each having a proximal end and adistal end into a bodily passage such that the distal end of thecatheter is disposed in the bodily passage. Another step 504 comprisesnavigating the distal end of the guide member towards a point oftreatment. Another step 506 comprises navigating the distal end of thecatheter towards a point of treatment within said bodily passage.Another step 508 comprises rotating the guide member towards a point oftreatment. Another step 510 comprises advancing the guide member andcatheter to a point of treatment. Another step 512 comprises passing afluid through the inflation lumen and into the second balloon with apressure sufficient to inflate the second balloon and provide contactbetween a portion of the first balloon and the passage wall. Anotherstep 514 comprises passing a medication through the infusion lumen andinto the first balloon with a pressure sufficient to expel themedication through one or more pores. Another step 516 comprisesstopping the passing a medication through the infusion lumen and intothe first balloon. Another step 518 comprises removing a portion of thefluid from the second balloon. Another step 520 comprises withdrawingthe distal end of the guide member and catheter from the bodily passage.

The step of inserting the distal end of a guide member and catheter intoa bodily passage can be accomplished using the exemplary guide memberand catheter described above with reference to FIG. 3. However, whilethe exemplary guide member and catheter described above with referenceto FIG. 3 has been described below as accomplishing the method oftreatment associated with FIG. 5, other catheter configurations, and/ormedical devices, such as those described herein can be utilized toaccomplish the method of treatment associated with FIG. 5, and skilledartisans will be able to select an appropriate catheter and/or medicaldevice according to a particular embodiment based on variousconsiderations, such as the procedure intended to be accomplished, amongothers.

The step of advancing the guide member and catheter to a point oftreatment can be accomplished as a single step or can be completed astwo separate steps. For example, alternative to accomplishing the stepof advancing the catheter and guide member to a point of treatment, astep comprising advancing the guide member to a point of treatment and astep of advancing the catheter to a point of treatment can beaccomplished separately.

The step of passing a fluid through the inflation lumen and into thesecond balloon with a pressure sufficient to inflate the second balloonand provide contact between a portion of, the entirety of, or a majorityof, the first balloon and the passage wall can be accomplished byintroducing a fluid into the inflation port to advance the secondballoon from its deflated to its inflated configuration. The amount ofthe exterior surface of the first balloon contacting the passage wall,and the amount of pressure exerted by the exterior surface of the firstballoon onto the passage wall, will depend on the amount fluid beingpassed into the inflation chamber of the second balloon. For example, inprocedures where a large amount of contact and pressure are desiredbetween the exterior surface of the first balloon and the passage wall,a larger amount of fluid will be passed through the inflation port intothe inflation chamber. In another example, in procedures where a smalleramount of contact and pressure are desired between the exterior surfaceof the first balloon and the passage wall, a smaller amount of fluidwill be passed through the inflation port into the inflation chamber.Examples of pressures considered suitable include pressures in the rangefrom about 1 ATM to about 12 ATM.

The step of passing a medication through the infusion lumen into thefirst balloon with a pressure sufficient to expel the medication throughthe one or more pores can be accomplished by passing a medicationthrough the infusion port and infusion lumen. This step can beaccomplished prior, during, or subsequent to passing a fluid into theinflation chamber. The medication can be passed into the infusion lumenusing any suitable device (e.g., a syringe in communication with theinfusion lumen). By inflating the second balloon to a pressure suitableto provide contact between the exterior surface of the first balloon andthe passage wall, the medication being expelled by the one or more porescan advantageously be infused into the passage wall defining the bodilypassage. It is considered advantageous to pass medication through theinfusion lumen and into the first balloon while the second balloon is inits inflated configuration to infuse the medication within the passagewall.

For example, in procedures where it is desired to infuse a larger amountof medication at a point of treatment, a larger amount of fluid will bepassed through the inflation port into the inflation chamber. Thus,providing a larger amount of contact and pressure between the exteriorsurface of the first balloon and the passage wall. In another example,in procedures where it is desired to infuse a smaller amount ofmedication at a point of treatment, a smaller amount of fluid will bepassed through the inflation portion into the inflation chamber. Thus,providing a smaller amount of contact and pressure between the exteriorsurface of the first balloon and the passage wall. Examples of pressuresconsidered suitable to expel the medication through the one or morepores and infuse the medication into the wall defining the bodilypassage include pressures in the range from about 1 ATM to about 10 ATM.Skilled artisans will appreciate however, that the pressure required toinfuse the medication will correlate with the inflated pressure of thefirst balloon.

The medication can comprise any suitable fluid, drug, and/or agent usedto treat a patient. Examples of medications considered suitable include,but are not limited to, anti-inflammatories (e.g., steroids),antineoplastics (e.g., mitomycin), cytotoxics, adrenaline (e.g.,epinephrine), antibiotics, antifungal agents, and/or anti-proliferatives(e.g., such as those used on coronary stents), or a combination thereof.

While the steps of advancing the distal end of the catheter to a pointof treatment within said bodily passage, passing a fluid through theinflation lumen and into the second balloon with a pressure sufficientto inflate the second balloon, and provide contact between a portion ofthe first balloon and the passage wall, and passing a medication throughthe infusion lumen into the first balloon with a pressure sufficient toexpel the medication through one or more pores have been described asseparate steps, these steps can be accomplished concurrently. In analternative, the step of passing a medication through the infusion lumeninto the first balloon with a pressure sufficient to expel themedication through one or more pores can be accomplished prior to orconcurrently with the step of passing a fluid through the inflationlumen and into the second balloon with a pressure sufficient to inflatethe second balloon and provide contact between a portion of the firstballoon and the passage wall and/or the step of navigating the distalend of the catheter to a point of treatment within said bodily passage.

The step of stopping the step of passing a medication through theinfusion lumen and into the first balloon can be accomplished byterminating the passing of the medication through the infusion lumen. Inan example where a syringe is the device passing the medication into theinfusion lumen, this can be accomplished by the user removing pressurefrom the plunger of the syringe.

While the steps of stopping the step of passing a medication through theinfusion lumen and into the first balloon and removing a portion of thefluid from the second balloon have been described as separate steps,these steps can be accomplished concurrently. In another alternative,the step of stopping the step of passing a medication through theinfusion lumen and into the first balloon can be accomplished prior tothe step of removing a portion of the fluid from the second balloon.

While the steps of passing a medication through the infusion lumen intothe first balloon with a pressure sufficient to expel the medicationthrough one or more pores, removing a portion of the fluid from thesecond balloon, and withdrawing the distal end of the catheter from thebodily passage have been described as separate steps, these steps can beaccomplished concurrently. In another alternative, the steps of passinga medication through the infusion lumen into the first balloon with apressure sufficient to expel the medication through one or more poresand removing a portion of the fluid from the second balloon can beaccomplished concurrently and the step of withdrawing the distal end ofthe catheter can subsequently be accomplished. In another alternative,the step of passing a medication through the infusion lumen into thefirst balloon with a pressure sufficient to expel the medication throughone or more pores can be accomplished and the steps of removing aportion of the fluid from the second balloon and withdrawing the distalend of the catheter from the bodily passage can be accomplishedsubsequently and concurrently.

Optionally, the step of stopping the step of passing a medicationthrough the infusion lumen and into the first balloon can beaccomplished and the steps removing a portion of the fluid from thesecond balloon and withdrawing the distal end of the catheter from thebodily passage can be accomplished concurrently.

An optional step comprising inflating the second balloon to a pressuresufficient to damage the passage wall surrounding the exterior surfaceof the first balloon can also be included in the method of treatment.This step can be performed after, or replace, the step of passing afluid through the inflation lumen and into the second balloon with apressure sufficient to inflate the second balloon and provide contactbetween a portion of the first balloon and the passage wall. This stepcan be accomplished by inflating the second balloon to a pressure in therange from about 2 ATM to about 18 ATM. It is considered advantageous todamage the passage wall to create a larger anatomical passageway. Anadditional optional step comprises reducing the pressure of the secondballoon after damaging the passage wall to a pressure sufficient toprovide contact between a portion of the first balloon and the passagewall. This step can be accomplished by removing a portion of the fluidfrom the inflation chamber until a desired pressure is reached.

While various catheter configurations, steps, alternative steps, andoptional steps have been described above with respect to treating tissuein a bodily passage, these catheter configurations, steps, alternativesteps, and optional steps can be included in, accomplished concurrentlywith, and/or accomplished in the alternative to, the methodologies,catheter configurations, steps, alternative steps, and/or optional stepsdescribed above and/or below with respect to treating tissue in a sinuscavity, airway, and/or sinus passage.

FIG. 6 is a flowchart representation of an exemplary method 600 oftreating tissue in a sinus cavity defined by a cavity wall. The method600 is similar to that described above with respect to method 500,except as described below. An initial step 602 comprises inserting aguide member and catheter each having a proximal end and a distal endinto a sinus passage such that the distal end of a catheter is disposedin the sinus passage of a patient. Another step 604 comprises navigatingthe distal end of the guide member towards a point of treatment in asinus cavity. Another step 606 comprises navigating the distal end ofthe catheter towards a point of treatment within a sinus cavity. Anotherstep 608 comprises rotating the guide member towards a point oftreatment. Another step 610 comprises advancing the guide member andcatheter to a point of treatment. Another step 612 comprises passing afluid through the inflation lumen and into the second balloon with apressure sufficient to inflate the second balloon and damage the cavitywall. Another step 614 comprises removing a portion of the fluid fromthe second balloon to a pressure sufficient to provide contact between aportion of the first balloon and the cavity wall to allow medication tobe delivered through the pores of the first balloon. Another step 616comprises passing a medication through the infusion lumen and into thefirst balloon with a pressure sufficient to expel the medication throughthe one or more pores. Another step 618 comprises stopping the step ofpassing a medication through the infusion lumen and into the firstballoon. Another step 620 comprises removing a portion of the fluid fromthe second balloon. Another step 622 comprises withdrawing the distalend of the guide member and catheter from the sinus cavity. Another step624 comprises withdrawing the distal end of the guide member andcatheter from the sinus passage.

The sinus passage and/or cavity wall can be treated using any of theherein described methods and/or steps by advancing the distal end of oneor more of the devices described herein through a primary ostium, anaccessory ostium, and/or a ventilation tube disposed in a cavity wall.For example, the step of advancing the catheter to a point of treatmentcan be accomplished by advancing the catheter over the previouslycannulated guide member 100 to a point of treatment.

The step of rotating the guide member towards a point of treatment canbe accomplished, as described above, and includes rotating the distalend of the coil member towards the face of a patient to confirmplacement of the distal end of the catheter in the proper sinus cavity.For example, when treating the frontal sinus, the guide member can berotated towards the forehead of the patient to allow the user to confirmproper placement of the guide member in the frontal sinus.

The steps of passing a fluid through the inflation lumen and into thesecond balloon with a pressure sufficient to inflate the second balloonand damage the cavity wall and removing fluid from the second balloon toa pressure sufficient to provide contact between a portion of the firstballoon and the cavity wall are both optional. For example, in analternative method, the steps of passing a fluid through the inflationlumen and into the second balloon with a pressure sufficient to inflatethe second balloon and damage the cavity wall and removing fluid fromthe second balloon to a pressure sufficient to provide contact between aportion of the first balloon and the cavity wall can be omitted andreplaced with a step comprising passing a fluid through the inflationlumen and into the second balloon with a pressure sufficient to inflatethe second balloon and provide contact between a portion of the firstballoon and the cavity wall. It is considered advantageous to passmedication through the infusion lumen into the first balloon when thesecond balloon is in its inflated configuration (e.g., damaging thecavity wall and/or contacting the cavity wall) so that the medicationcan be infused within the cavity wall. The step of passing fluid throughthe inflation lumen and into the second balloon with a pressuresufficient to inflate the second balloon and provide contact between aportion of the first balloon and the cavity wall can be accomplished byinflating the second balloon to a pressure in the range from about 1 ATMto about 12 ATM.

In a further alternative, the step of passing a fluid through theinflation lumen and into the second balloon with a pressure sufficientto inflate the second balloon and damage the cavity wall can beaccomplished and the step of removing fluid from the second balloon to apressure sufficient to provide contact between a portion of the firstballoon and the cavity wall can be omitted. This advantageously allowsfor the infusion of medication while the second balloon is inflated to apressure sufficient to damage the cavity wall.

While various catheter configurations, steps, alternative steps, andoptional steps have been described above with respect to treating tissuein a sinus cavity, these catheter configurations, steps, alternativesteps, and optional steps can be included in, accomplished concurrentlywith, and/or accomplished in the alternative to, the methodologies,catheter configurations, steps, alternative steps, and/or optional stepsdescribed above and/or below with respect to treating tissue in a bodilypassage, airway, and/or sinus passage.

FIG. 7 is a flowchart representation of an exemplary method 700 oftreating tissue within an airway defined by an airway wall. The method700 is similar to that described above with respect to method 500,except as described below. An initial step 702 comprises inserting aguide member and catheter each having a proximal end and a distal endinto an airway such that the distal end is disposed in the airway.Another step 704 comprises navigating the distal end of the guide membertowards a point of treatment with the airway. Another step 706 comprisesnavigating the distal end of the catheter towards a point of treatmentwithin the airway. Another step 708 comprises rotating the guide membertowards a point of treatment. Another step 710 comprises advancing theguide member and catheter to a point of treatment within the airway.Another step 712 comprises passing a fluid through the inflation lumenand into the second balloon with a pressure sufficient to inflate thesecond balloon and dilate the point of treatment within the airway.Another step 714 comprises removing a portion of the fluid within thesecond balloon to a pressure sufficient to provide contact between aportion of the first balloon and the airway wall. Another step 716comprises passing a medication through the infusion lumen and into thefirst balloon with a pressure sufficient to expel the medication throughthe one or more pores. Another step 718 comprises stopping passing themedication through the infusion lumen. Another step 720 comprisesremoving a portion of the fluid from the second balloon. Another step722 comprises withdrawing the distal end of the guide member andcatheter from the airway.

The step of dilating the second balloon to a pressure sufficient todilate the point of treatment (e.g., stricture) can be accomplished byinflating the second balloon to a pressure in the range from about 2 ATMto about 12 ATM.

The steps of passing a fluid through the inflation lumen and into thesecond balloon with a pressure sufficient to inflate the second balloonand dilate the point of treatment within the airway and removing aportion of the fluid within the second balloon to a pressure sufficientto provide contact between a portion of the first balloon and the airwaywall are both optional. For example, in an alternative, the steps ofpassing a fluid through the inflation lumen and into the second balloonwith a pressure sufficient to inflate the second balloon and dilate thepoint of treatment within the airway and removing a portion of the fluidwithin the second balloon to a pressure sufficient to provide contactbetween a portion of the first balloon and the airway wall can beomitted and replaced with a step comprising passing a fluid through theinflation lumen and into the second balloon with a pressure sufficientto provide contact between a portion of the first balloon and the airwaywall. It is considered advantageous to pass medication through theinfusion lumen into the first balloon when the second balloon is in itsinflated configuration (e.g., dilating the airway wall and/or contactingthe airway wall) so that the medication can be infused within the airwaywall.

In a further alternative, the step of passing a fluid through theinflation lumen and into the second balloon with a pressure sufficientto inflate the second balloon and dilate the point of treatment withinthe airway can be accomplished and the step of removing a portion of thefluid within the second balloon to a pressure sufficient to providecontact between a portion of the first balloon and the airway wall canbe omitted. This advantageously allows for the infusion of medicationwhile the second balloon is inflated to a pressure sufficient to dilatethe point of treatment (e.g., a stricture).

The methods described herein can alternatively be used to treat one ormore strictures within an airway. For example, the step of advancing thedistal end of the catheter to a point of treatment within said airwaycomprises navigating the distal end past the stricture within theairway. Furthermore, the step of passing a fluid through the inflationlumen and into the second balloon with a pressure sufficient to inflatethe second balloon and dilate the point of treatment within the airwaycan comprise dilating a stricture within an airway. While the step ofadvancing the distal end of the catheter past a stricture has beendescribed, the distal end of the catheter can alternatively be navigatedproximal to, or within, the stricture.

While various catheter configurations, steps, alternative steps, andoptional steps have been described above with respect to treating tissuein an airway, these catheter configurations, steps, alternative steps,and optional steps can be included in, accomplished concurrently with,and/or accomplished in the alternative to, the methodologies, catheterconfigurations, steps, alternative steps, and/or optional stepsdescribed above/or below with respect to treating tissue in a bodilypassage, sinus cavity, airway, and/or sinus passage.

FIG. 8 is a flowchart representation of an exemplary method 800 oftreating tissue within an airway defined by an airway wall. The method800 is similar to that described above with respect to method 700,except as described below. An initial step 802 comprises activating avisualization device. Another step 804 comprises confirming operation ofthe visualization device. Another step 806 comprises inserting a guidemember and catheter each having a proximal end and a distal end into anairway such that the distal end of the catheter is disposed in theairway. Another step 808 comprises navigating the distal end of theguide member towards a point of treatment within the airway. Anotherstep 810 comprises navigating the distal end of the catheter towards apoint of treatment within the airway. Another step 812 comprisesrotating the guide member towards a point of treatment. Another step 814comprises advancing the guide member and catheter to a point oftreatment. Another step 816 comprises confirming placement of thecatheter. Another step 818 comprises passing a fluid through theinflation lumen and into the second balloon with a pressure sufficientto inflate the second balloon and dilate the point of treatment withinthe airway. Another step 820 comprises removing a portion of the fluidwithin the second balloon to a pressure sufficient to provide contactbetween a portion of the first balloon and the airway wall. Another step822 comprises passing a medication through the infusion lumen and intothe first balloon with a pressure sufficient to expel the medicationthrough the one or more pores. Another step 824 comprises stoppingpassing the medication through the infusion lumen. Another step 826comprises removing the fluid from the second balloon. Another step 828comprises withdrawing the distal end of the guide member and catheterfrom the airway.

The step of activating a visualization device can be accomplished byactivating a light source associated with an optical fiber disposedwithin the catheter and/or activating a camera disposed within thecatheter. The optical fiber and/or camera can be disposed on an interiorsurface of a lumen of the catheter, embedded within the wall of thecatheter, and/or disposed on an exterior surface of the catheter. Whenan optical fiber is disposed within the catheter, the light source isadapted to be attached to the optical fiber, which is adapted to emitlight radially and/or axially from the distal end of the optical fiber.When a camera is disposed within the catheter, the camera is adapted tocapture images from the distal end of the catheter and/or from thecircumference of the catheter at any point along the catheter length.The camera is adapted to be attached to a display and/or power sourceand can provide still and/or live footage to the display for review bythe user. Alternatively, multiple cameras can be used in conjunctionwith, or separate from, one another. The camera can comprise a wired orwireless camera that can transmit images to a display and/or a storagedevice.

The step of confirming operation of the visualization device can beaccomplished by the user verifying that light is being emitted from theoptical fiber when the light source has been activated and/or the userverifying that the camera is capturing images and displaying the imageson a display when the camera has been activated. The light source and/orcamera can be disposed in the lumen defined by the guide member and/or alumen defined by the catheter, or other medical device, such as thosedescribed herein.

The step of confirming placement of the catheter can be accomplishedtranscutaneously and/or via images provided on a display. In an example,confirming proper placement of the distal end of the catheter at a pointof treatment using transcutaneous visualization can be accomplished byvisualizing the intensity of the light being emitted from the opticalfiber transcutaneously to determine if the intensity is indicative ofproper positioning of the distal end of the catheter. In anotherexample, confirming proper placement of the distal end of the catheterat a point of treatment can be accomplished by viewing images providedon a display and determining if the images indicate proper positioningof the distal end of the catheter at a point of treatment. If the distalend is confirmed as being properly placed at a point of treatment, thestep ends. However, if it is determined that placement of the distal endof the catheter is not proper, further navigation of the distal end ofthe catheter may be necessary.

While various catheter configurations, steps, alternative steps, andoptional steps have been described above with respect to treating tissuein an airway, these catheter configurations, steps, alternative steps,and optional steps can be included in, accomplished concurrently with,and/or accomplished in the alternative to, the methodologies, catheterconfigurations, steps, alternative steps, and/or optional stepsdescribed above and/or below with respect to treating tissue in a bodilypassage, sinus cavity, airway, and/or sinus passage.

FIG. 9 is a flowchart representation of an exemplary method 900 oftreating tissue within a sinus passage (e.g., eustachian tube) definedby a passage wall. The method 900 is similar to that described abovewith respect to method 800, except as described below. An initial step902 comprises activating a visualization device. Another step 904comprises confirming operation of the visualization device. Another step906 comprises inserting a guide member and catheter each having aproximal end and a distal end into a sinus passage such that the distalend of the catheter is disposed in the sinus passage. Another step 908comprises navigating the distal end of the guide member towards a pointof treatment. Another step 910 comprises navigating the distal end ofthe catheter towards a point of treatment within the sinus passage.Another step 912 comprises rotating the guide member towards a point oftreatment. Another step 914 comprises advancing the guide member andcatheter to a point of treatment. Another step 916 comprises confirmingplacement of the catheter. Another step 918 comprises passing a fluidthrough the inflation lumen and into the second balloon with a pressuresufficient to inflate the second balloon and provide contact between aportion of the first balloon and the passage wall. Another step 920comprises passing a medication through the infusion lumen and into thefirst balloon with a pressure sufficient to expel the medication throughthe one or more pores. Another step 922 comprises stopping passing themedication through the infusion lumen. Another step 924 comprisesremoving the fluid from the second balloon. Another step 926 compriseswithdrawing the distal end of the guide member and catheter from thesinus passage.

The step of passing a medication through the infusion lumen and into thefirst balloon with a pressure sufficient to expel the medication throughthe one or more pores can be accomplished by passing any suitable fluid,drug, and/or agent through the one or more pores. Examples ofmedications considered suitable include, but are not limited to,anti-inflammatories (e.g., steroids), antineoplastics (e.g., mitomycin),cytotoxics, adrenaline (e.g., epinephrine), antibiotics, antifungalagents, and/or anti-proliferatives (e.g., such as those used on coronarystents), or a combination thereof.

While various catheter configurations, steps, alternative steps, andoptional steps have been described above with respect to treating tissuein a sinus passage, these catheter configurations, steps, alternativesteps, and optional steps can be included in, accomplished concurrentlywith, and/or accomplished in the alternative to, the methodologies,catheter configurations, steps, alternative steps, and/or optional stepsdescribed above and/or below with respect to treating tissue in a bodilypassage, sinus cavity, and/or airway.

FIG. 10 is a flowchart representation of an exemplary method 1000 oftreating tissue in a sinus passage, defined by a passage wall, incommunication with two or more sinus cavities using a light source. Anysuitable medical device that defines at least one lumen extendingbetween the proximal end and the distal end can be used to accomplishthis method, and skilled artisans will be able to select a suitablemedical device according to a particular embodiment based on variousconsiderations, including the intended use of the device. Exampledevices considered suitable to advance over a length of an elongatetubular member include, but are not limited to, catheters, irrigationcatheters, balloon catheters, the catheters described herein (e.g.,catheter 200, catheter 300), and any other suitable medical device. Inthis exemplary method, the guide member omits the inclusion ofprojection 160 and has a fitting 180 releasably attached to the proximalend 122 of the elongate tubular member 120. Again, any suitable medicaldevice that defines at least one lumen can be used in combination withthe guide member.

An initial step 1002 comprises inserting a guide member having aproximal end and a distal end into said sinus passage such that thedistal end of the guide member is disposed in the sinus passage. Anotherstep 1004 comprises rotating the guide member towards a point oftreatment. Another step 1006 comprises navigating the distal end of theguide member towards a point of treatment within said sinus cavity.Another step 1008 comprises connecting the distal end of the opticalfiber to said light source. Another step 1010 comprises activating thesaid light source such that light emits from the distal end of theoptical fiber. Another step 1012 comprises visualizing light beingemitted from the optical fiber and passing through an area of skin ofsaid patient. Another step 1014 comprises verifying that the location atwhich the light passes through the skin of said patient is indicative ofthe sinus cavity intended to be treated. Another step 1016 comprisesadvancing a medical device having a proximal end, a distal end, anddefining at least one lumen along the path defined by the previouslyplaced guide member into said sinus passage and into the sinus cavitysuch that the distal end of the medical device is disposed in the sinuscavity. Another step 1018 comprises treating said tissue within thesinus cavity by using the medical device. Another step 1020 compriseswithdrawing the distal end of the medical device from the sinus cavityand sinus passage. Another step 1022 comprises withdrawing the distalend of the guide member from the sinus cavity and sinus passage.

By releasably attaching the fitting 180 to the proximal end of theelongate tubular member 120 and omitting the projection 160 a user canadvance any suitable medical device over the guide member to perform aprocedure. A skilled artisan will be able to select a suitable medicaldevice according to a particular embodiment based on variousconsiderations, including the procedure intended to be performed.

The step of inserting the distal end of a guide member into a sinuspassage such that the distal end of the guide member is disposed in thesinus passage can be accomplished by a user locating the sinus passageand advancing the distal end of the guide member into the sinus passage.

The step of rotating the guide member towards a point of treatment canbe accomplished by a user rotating the guide member (e.g., fitting 180)in a clockwise or counterclockwise direction around the lengthwise axisof the elongate tubular member. For example, to align the distal end ofthe coil member with an entrance of a sinus cavity when two or moresinus cavities are present, the user can rotate the guide member (e.g.,fitting 180) in a clockwise or counterclockwise direction around thelengthwise axis of the elongate tubular member to properly positionedthe distal end of the guide member towards the sinus cavity intended tobe treated.

The step of navigating the distal end of the guide member towards apoint of treatment within said sinus cavity can be accomplished by auser placing a distal force on any portion of the device to advance thedistal end of the guide member into the sinus cavity.

The step of connecting the distal end of the optical fiber to the lightsource can be accomplished by a user connecting the distal end to thelight source using any suitable method of attachment, and skilledartisans will be able to select a suitable method of attachment based onvarious considerations, including the intended use of the device. Anexample method considered suitable, includes, but is not limited to,using a fiber coupling.

The step of activating the light source can be accomplished by a userturning on the light source (e.g., power supply) such that the light isemitted from the light source and/or optical fiber.

The step of visualizing light being emitted from the optical fiber andpassing through an area of skin of said patient can be accomplished by auser reviewing the patient and locating the light being emitted from theoptical fiber transcutaneously.

The step of verifying that the location at which the light passesthrough the skin of said patient is indicative of the sinus cavityintended to be treated can be treated by the user determining that thelight being viewed transcutaneously is indicative of the distal end ofthe guide member being positioned in the sinus cavity intended to betreated.

The step of advancing a medical device having a proximal end, a distalend, and defining at least one lumen along the path defined by thepreviously placed guide member into said sinus passage and into thesinus cavity such that the distal end of the medical device is disposedin the sinus cavity can accomplished by removing the fitting of theguide member and inserting the proximal end of the guide member into theat least one lumen defined by the medical device and subsequentlysliding the medical device distally over the guide member. An optionalstep includes reattaching the fitting to the proximal end of the guidemember subsequent to the medical device being passed over a length ofthe guide member.

Alternatively, if the fitting is omitted, the medical device can beadvanced over the guide member without removing, or replacing, thefitting on the proximal end of the guide member.

The step of treating said tissue within the sinus cavity by using themedical device can be accomplished using any suitable method oftreatment, and skilled artisans will be able to select a suitable methodof treatment according to a particular embodiment based on variousconsiderations, including the bodily passage intended to be treated.Example methods of treatment considered suitable include, but are notlimited to, those described herein, dilating a stricture, irrigating thesinus cavity, providing suction within the sinus cavity, removing one ormore objects, or any other suitable method.

The steps of withdrawing the medical device and guide member from thesinus cavity and sinus passage can be accomplished by the user placing aproximal force on each of the medical device and guide member, incombination or separately, until they are completely removed from thesinus cavity and sinus passage.

While various catheter configurations, steps, alternative steps, andoptional steps have been described above with respect to treating tissuein a sinus passage, these catheter configurations, steps, alternativesteps, and optional steps can be included in, accomplished concurrentlywith, and/or accomplished in the alternative to, the methodologies,catheter configurations, steps, alternative steps, and/or optional stepsdescribed above with respect to treating tissue in a bodily passage,sinus cavity, airway, and/or sinus passage.

The foregoing detailed description provides exemplary embodiments of theinvention and includes the best mode for practicing the invention. Thedescription and illustration of embodiments is intended only to provideexamples of the invention, and not to limit the scope of the invention,or its protection, in any manner.

We claim:
 1. A medical device adapted to be used with a light source forthe identification and treatment of a bodily passage, said medicaldevice comprising: an elongate tubular member having a first proximalend, a first distal end, a first lengthwise axis, and defining a firstlumen extending between the first proximal end and the first distal end;a coil member having a second proximal end, a second distal end, asecond lengthwise axis, and defining a curve and a second lumen, thecurve defined along the second lengthwise axis of the coil member anddisposed between the second proximal end and the second distal end, thecurve directing the second distal end away from the first lengthwiseaxis of the elongate tubular member, the second lumen extending betweenthe second proximal end and the second distal end, the second proximalend attached to the first distal end of the elongate tubular member; andan optical fiber disposed in the first lumen and the second lumen andhaving a third proximal end adapted to be operatively connected to saidlight source, the optical fiber attached to the coil member at a firstlocation proximal to the curve and a second location distal to thecurve.
 2. The medical device of claim 1, further comprising a projectiondisposed on the elongate tubular member and extending radially outwardfrom the elongate tubular member; and further comprising a cathetercomprising an elongate main body having a fourth proximal end, a fourthdistal end, and defining a third lumen and a recess, the third lumenextending between the fourth proximal end and the fourth distal end, therecess extending from the fourth proximal end into the third lumentoward the fourth distal end, the third lumen having a first diameterand the recess having a second diameter, the second diameter greaterthan the first diameter; wherein the elongate tubular member is disposedwithin the third lumen such that the projection is disposed within therecess defined by the catheter; and wherein the projection has anoutside diameter that is greater than the first diameter and less thanthe second diameter.
 3. The medical device of claim 1, wherein theoptical fiber is attached to the coil member at a third locationproximal to the first location.
 4. The medical device of claim 1,wherein a portion of the optical fiber is attached to the elongatetubular member.
 5. The medical device of claim 1, further comprising afitting disposed on the first proximal end of the elongate tubularmember and extending radially outward from the elongate tubular member.6. The medical device of claim 5, wherein the fitting is releasablyattached to the elongate tubular member.
 7. The medical device of claim1, further comprising a camera disposed on the second distal end andadapted to transmit images to a display.
 8. The medical device of claim1, wherein the elongate tubular member and the coil member are formed ofthe same material.
 9. The medical device of claim 1, wherein the curveis preformed.
 10. A medical device adapted to be used with a lightsource for the identification and treatment of a bodily passage, saidmedical device comprising: a catheter comprising an elongate main bodyhaving a first proximal end, a first distal end, and defining a firstlumen and a recess, the first lumen extending between the first proximalend and the first distal end, the recess extending from the firstproximal end into the first lumen toward the first distal end, the firstlumen having a first diameter and the recess having a second diameter,the second diameter greater than the first diameter; an elongate tubularmember having a second proximal end, a second distal end, and defining asecond lumen extending between the second proximal end and the seconddistal end; a coil member having a third proximal end, a third distalend, and defining a curve and a third lumen, the curve disposed betweenthe third proximal end and the third distal end, the third lumenextending between the third proximal end and the third distal end, thethird proximal end attached to the second distal end of the elongatetubular member; an optical fiber disposed in the second lumen and thethird lumen and having a fourth proximal end adapted to be operativelyconnected to said light source, the optical fiber attached to the coilmember at a first location proximal to the curve and a second locationdistal to the curve; and a projection disposed on the elongate tubularmember and extending radially outward from the elongate tubular member,the projection having an outside diameter that is greater than the firstdiameter and less than the second diameter; wherein the elongate tubularmember is disposed within the first lumen such that the projection isdisposed within the recess defined by the catheter.
 11. The medicaldevice of claim 10, wherein the optical fiber is attached to the coilmember at a third location proximal to the first location.
 12. Themedical device of claim 10, wherein a portion of the optical fiber isattached to the elongate tubular member.
 13. The medical device of claim10, further comprising a fitting disposed on the second proximal end ofthe elongate tubular member and extending radially outward from theelongate tubular member.
 14. The medical device of claim 13, wherein thefitting is releasably attached to the elongate tubular member.
 15. Themedical device of claim 10, further comprising a camera disposed on thethird distal end and adapted to transmit images to a display.
 16. Themedical device of claim 10, wherein the elongate tubular member and thecoil member are formed of the same material.
 17. The medical device ofclaim 10, wherein the curve is preformed.
 18. A medical device adaptedto be used with a light source for the identification and treatment of abodily passage, said medical device comprising: an elongate tubularmember having a first proximal end and a first distal end, and defininga first lumen extending between the first proximal end and the firstdistal end; a coil member having a second proximal end and a seconddistal end, and defining a second lumen extending between the secondproximal end and the second distal end, the second proximal end attachedto the first distal end of the elongate tubular member; and an opticalfiber disposed in the first lumen and the second lumen and having athird proximal end adapted to be operatively connected to said lightsource and a third distal end attached to the coil member; wherein thecoil member is flexible and defines a preformed curve disposed betweenthe second proximal end and the second distal end, the curve directingthe second distal end away from the first lengthwise axis of theelongate tubular member.
 19. The medical device of claim 18, wherein theoptical fiber is attached to the coil member at a first locationproximal to the curve and a second location distal to the curve.
 20. Themedical device of claim 18, wherein a portion of the optical fiber isattached to the elongate tubular member.